Quality Assurance Associate

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Business Title: QA Associate 
Position Title: Quality Assurance III
Division: Consumer Products Services 
Entity: ATL
Location: Landis, NC
Reports to: Manager
FLSA: Non-exempt
 
Hours Worked: Typically, Monday through Friday 7:30 AM – 4:00 PM 
However, must be flexible to meet business needs or cover shifts a requested

Position Summary:
The QA Associate provides support to Third-Party Logistics and Warehousing, across the US (travel 20-30% of time). The QA Representative provides oversight of operations and directly manages quality functions, guidance to incoming material technicians and will advise on issues such as non-conformance investigations, change control proposals, procedures, commissioning, and qualification activities. This position will also support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections of materials and sampling of items (components, printed packaging materials, etc.) utilizing SAP and LIMS. The QA Associate position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.
Duties and Responsibilities:
It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.
•    Provide direct quality oversight of third-party operations.
•    Oversee third-party operations across the US, traveling as necessary for on-site support, inspections, and oversight.
•    Author, review and approve documents including, but not limited to, procedures, change control proposals, deviations, CARTS, and equipment qualifications.
•    Ensures all areas of oversight remain in quality compliance per SOPs and cGMP requirements.
•    Provide quality guidance and recommendations regarding materials, utilities, and maintenance.
•    Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
•    Participate in aberrant data investigations.
•    Provide coaching, feedback and mentoring to QA Technicians as it relates to execution of quality systems.
•    Work with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues. 
•    Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.  
•    Evaluating temperature excursions on shipments received at the warehouse.

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•    Identifies and assists in resolving issues on shipments (i.e. Incorrect quantity or product, contamination, etc.).
•    Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, Investigate customer complaints.)
•    Work closely with site customers to report and resolve issues and improve the process.
•    Participate in and/or support recalls, as appropriate.
•    Conduct gap assessments of global requirements and ensure implementation of the governing standards.
•    Participate in and/or lead self-inspection activities.
•    Participate in and/or support regulatory inspections and audits.
•    Maintain and improve quality systems.
•    Assist others in the interpretation of regulatory and corporate requirements.
•    Data Management & Archives
o    Managing company archives and fulfills client requests for raw data copies
o    Enter data into databases and maintain data integrity
o    Organize, maintain, and consolidate data within established protocols
o    Create reports and logbooks assigned
•    Documentation & Records
o    Maintain quality systems documentation, including procedures, forms, quality records, and external standards
o    Organize, index, file, and store all quality systems documentation and quality records
o    Receive, review, control, and track documents per established processes and procedures
o    Create and control QA forms, issuing them as needed
•    Operational Support
o    Order supplies and maintenance items as needed
o    Maintain site training and equipment records

o    Support client and company initiatives by providing basic QA support activities
o    Support client, safety, and regulatory body audits as assigned
o    Follow Bureau Veritas policies and procedures
•    Process Improvement
o    Identify gaps in the document control process and provide process improvements
o    Ensure the document control system remains compliant with current regulations
o    Maintain quality systems in company operations
•    Review & Approval Authority
o    Conduct quality review and approval of method validations
o    Assist in review and approve OOS and deviation investigations, ensuring proper change control/CAPA implementation.
o    Review approved Certificates of Analysis and calibration records
o    Review and approve instrument qualification and method validation documents
o    Manage the inspection and approval of laboratory data prior to release
•    System Development & Management
o    Develop, maintain, and enhance quality systems in company operations
o    Develop and implement quality and document control system procedures
o    Lead quality event tracking and trending activities
o    Manage internal audit scheduling and task assignments for trained QA personnel

•    Vendor & Equipment Management
o    Evaluate and approve supplier surveys for laboratory vendor qualification
o    Manage site laboratory equipment vendors providing repair, calibration, or preventive maintenance services
o    Maintain site Training and Equipment Tracking Matrices
o    Ensure site training and equipment systems are in an audit-ready state
•    Cross-Functional Leadership
o    Facilitate review and revision of procedures, specifications, and forms with functional departments
o    Participate in formal audit activities
o    Substitute for Quality I-III functions as necessary

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Skills & Proficiencies:
•    Written and verbal communication skills include the ability to communicate effectively in a group setting, with colleagues and clients 
•    Organizational and time management skills 
•    Ability to perform multiple tasks 
•    Ability to organize and prioritize workload to meet or exceed deadlines 
•    Individual and Team work ethic 
•    Proficiency with Windows, Word & Excel 
•    Attention to detail 
•    Positive attitude, self-motivated, high level of engagement
•    Demonstrated expertise in developing, maintaining, and improving quality systems
•    Advanced technical skills in method validation, equipment qualification, and data review
•    Ability to lead cross-functional teams in addressing quality issues and implementing corrective actions
•    Strong project management skills to coordinate quality initiatives across the organization
•    Excellent problem-solving and critical thinking abilities to identify and resolve complex quality challenges
•    Thorough understanding of relevant regulations, industry standards, and best practices

Education and Experience:
•    Bachelor’s Degree in logistics, manufacturing, quality assurance or closely related field
•    Minimum of 5 year(s) of experience with GMP, warehouse or manufacturing environment

An equivalent combination of education and experience may be accepted in lieu of above.

Compensation Range: 
$28 - $34 an hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).

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